Infection Prevention Control Endoscopy Unit
Transcript of Infection Prevention Control Endoscopy Unit
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Kathy Zegarski BS, CIC
Kettering Medical Center
Infection Prevention and Control
March 6, 2010
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Objectives
Discuss issues and standardsassociated with infection prevention in
the endoscopy setting
Identify possible sources of infection inthe endoscopy setting
Discuss the categories and use ofcleaning and disinfecting agents in
reprocessing endoscopy equipment
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Hopefully you will learn..
How infections are transmitted Common pathogens Common modes of transmission in
endoscopy suites
Cleaning, disinfection and sterilization ofequipment and environment
Levels of disinfection and their specific use Recommended guidelines for endoscopy
equipment
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Pathway of Disease Transmission
Transmission-based PrecautionsContact Precautions Direct Indirect
Droplet PrecautionsAirborne Precautions
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Contact Transmission
Direct Contact Transmission Transfer of microorganisms from one person
to another without and intermediary object
Occupational exposure without a device Herpetic whitlow or scabies
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Contact Transmission
Indirect Contact Transmission Transfer of microorganisms from one person
to another by means of a contaminated
intermediary object
Contaminated hands Improperly cleaned endoscopes, equipment
or environment
Contaminated medication vials
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Droplet Transmission
Droplet Transmission Large droplet (most > 5 m) usually < 3
feet but may be 6-10 feet
Mostly respiratory agents (Influenza,Pertussis GAS, Bacterial Meningitis)
Also proven mode of transmission forNorovirus and Rotavirus
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Airborne Transmission
Airborne Transmission Droplet nuclei (< 5 m) remain suspended
for long distances or dust particles/spores
containing microorganisms
Inhaled by another person Requires special air handling TB, Rubeola, Varicella, Variola
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Common Pathogens in GI
Prior to 1988, not uncommon (253reported)
1988 adoption of 1stendoscopereprocessing guidelines
Post 1988, 28 reported cases Transmission of exogenous flora Transmission of endogenous flora
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Common Pathogens in GI GI Pathogens
GI Viruses (Noro, Rota) C. difficile Salmonella Gram Negative Rods (GNR)
Pseudomonas
E. coli
S. aureus Enterococcus
Non-GI Pathogens HIV, HBV, HCV vCJD Mycobacterium
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Common Pathogens Gastrointestinal viruses
Norovirus Cruise ship virus Can not be grown in culture Modes of transmission Can be resistant to > 10 ppm chlorine Phenolics are usually effective virucidal
Rotavirus Typically pediatric outbreaks Very stable Mode of transmission Disinfectants
Not identified as attributable to outbreaks fromendoscopes
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Common Pathogens
C. difficile Pathogenicity Mode of transmission Spore-forming bacteria (Ubiquitous) Vegetative vs. spore state Special environmental cleaning
recommendations
Hand hygiene considerations Colonization vs. infection Potential pathogen for outbreaks
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Common Pathogens
Salmonella~3% chronic carrier state
post infection
Outbreaks due toimproper cleaning ofendoscopes and suite
Infection usually smallintestine, but can cause
colitis
Exogenous orendogenous
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Common Pathogens
Pseudomonas spp.
Ubiquitous in soil and water Large producer of BiofilmAssociated with several endoscopy
outbreaks
Proper cleaning and final rinsing imperativeto reduce the risk of infection
Commonly resistant to multiple antibiotics Mostly exogenous spread
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Common Pathogens
E. coli/Klebsiella spp. (Enterobacteriaceae) Normal GI flora Not associated with large outbreaks Common organism for endogenous
transmission
ESBL producers (3rdgenerationcephalosporins)
Klebsiella also a Carbapenemase producer(Carbapenems)
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Common Pathogens
Staphylococcus aureus/Enterococcus
Both GI flora Enterococcus 100%, Staph 30-50% Endogenous or exogenous MRSA/VRSA VRE Both susceptible to disinfectants
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Common Pathogens
HIV/HBV
No documented cases of transmission inendoscopy for HIV
A few older questionable cases of HBV HIV very unstable HBV very stable Proper cleaning and disinfection OSHA BBP rule to protect you the HCW
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Common Pathogens
HCV Primarily spread blood-to-blood Documented cases of transmission of HCV due to
high level disinfection (HLD) lapsed
Failure to sterilize biopsy forceps between patients Failure to mechanically clean working channel of
endoscope prior to disinfection
Identified in inadequate aseptic techniques Contaminated IV tubing or bags, syringes, multi-
dose vials
Las Vegas Endoscopy Suites
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Common Pathogens
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(Un)Common Pathogens
Variant Creutzfeldt-Jacob Disease (vCJD) Neurologic disease transmitted by
proteinacous agent called prions
Highly infectious: brain, dura mater, pituitary,eye
Must less infectious in lymphoid tissue,tonsil, appendix, ileum, rectum
European Society for Gastroenterologistsrecommendations
Dedicated scope Destroy after use
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Common Pathogens
Mycobacterium spp.
Tuberculosis Documented
transmission due to
inadequate HLD
Lapses in AutomaticEndoscope
Reprocessors (AERs)
Intracellulare Lapses in AERs
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Causes of Transmission
Environmental contamination Equipment Device integrity Inadequate preprocessing Failure in reprocessors
Chemical failure Staff knowledge and training
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Causes of Transmission
Environmental contamination Endoscopy suite (TJC) IC.02.02.01 : The hospital reduces the risk of
infections associated with medical
equipment, devices, and supplies
Decontamination room separate from cleanstorage or patient care areas
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Transmission of Infections
Layout (AIA) Endoscopy suites may be divided into 3 major functional areas:
Procedure Room (200 ft2) Instrument processing room(s)
Ventilation (10 Air exchanges/hr, negative pressure, no recirculation) 2 sinks (handwashing, equipment)
Patient holding/preparation and recovery room/area (80 ft2/pt)
Storage of scopes(AORN) Closed, well ventilated cabinet not touching one another Adequate height to allow scope to hang vertically and not touch
bottom
Internal walls must be surface cleanable (weekly or monthly),preferably with scope protectors separating scopes
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Causes of Transmission
Equipment
Inadequate pre-cleaning Inadequate HLD Inadequate drying; no use of alcohol
and/or air
Reusable brushes Defaults or breakdown in scopesAER or reprocessor malfunctions
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Causes of Transmission
Chemical Failure
Failure to replace solutions (most 14-28days)
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ReprocessingofSingle-UseDevices/UCM133514
Improper solution dilution/outdatedsolution Must monitor reuse Visually inspect
Wrong solution28
Causes of Transmission
Staff knowledge and training
Personnel must demonstrate ongoingcompetency in the use, care andprocessing of flexible endoscopes andrelated equipment Education specific to type and design of scopes
used and procedures performed
Periodically and before new scopes or otherequipment are introduced into the practice
Understanding of cleaning, disinfection andsterilization
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Causes of Transmission
Training MUST include: Set up/Breakdown Cleaning Disinfection/sterilization Storage SUDs
Periodically retrain and assesscompetence
Follow manufacturer recommendations30
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Cleaning, Disinfection and
Sterilization
All items in healthcare facilities are subjectto cleaning, disinfection or sterilization.
CDC Guideline for Disinfection andSterilization in Healthcare Facilities, 2008.
EH Spaulding believed that an objectsintended use determined how to disinfect it.
Classification scheme designed based on risk ofinfection for an items intended use.
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Cleaning, Disinfection and
Sterilization
EH Spaulding Scheme Critical Sterilization
Semicritical High Level Disinfection
Noncritical Intermediate or Low Level Disinfection
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Cleaning, Disinfection and
Sterilization Cleaning
the removal of visible soil (e.g., organic andinorganic material) from objects and surfaces andnormally is accomplished manually or mechanicallyusing water with detergents or enzymatic products.
Disinfection a process that eliminates many or all pathogenic
microorganisms, except bacterial spores, oninanimate objects .
Sterilization a process that destroys or eliminates all forms of
microbial life and is carried out in health-carefacilities by physical or chemical methods.
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Cleaning, Disinfection and
Sterilization
CRITICAL Objects which enter normallysterile tissue or the vascular systemmust be subjected to sterilizationbecause these objects if contaminated
can transmit disease. Surgical Equipment Endoscopes entering sterile body sites Cardiac and urinary catheters Implantable items Ultrasound probes used in sterile body sites
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Cleaning, Disinfection and
Sterilization
Sterilization Methods kill allmicroorganisms including all spores.
Methods include: Steam Ethylene Oxide (Gas) Hydrogen Peroxide Plasma (Gas Plasma) Ozone VHP Chemical
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Cleaning, Disinfection and
Sterilization
Chemical sterilants include: >2.4% glutaraldehyde-based formulations, 0.95% glutaraldehyde with 1.64% phenol/phenate 7.5% stabilized H2O2 0.2% peracetic acid 7.35% H2O2 with 0.23% peracetic acid 0.08% peracetic acid with 1.0% H2O2
(Follow manufacturer exposure times)
Liquid chemical sterilants reliably produce sterility onlyif cleaning precedes treatment and if properguidelines are followed regarding concentration,contact time, temperature, and pH.
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Cleaning, Disinfection and
Sterilization
Steam Sterilization Advantages Inexpensive Non-toxic QC easy Rapid effective microbicidal Rapid cycle times Excellent medical packaging penetration
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Cleaning, Disinfection and
Sterilization
Disadvantages Potential for burns to staff Heat labile instruments May leave instruments wet
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Cleaning, Disinfection and
Sterilization
Ethylene Oxide (ETO) Advantages Effective Microbicidal Excellent package penetration Inexpensive Operation and QC easy
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Cleaning, Disinfection and
Sterilization
ETO Disadvantages Potentially hazardous to patients and staff Lengthy cycles CFC banned post 1985 Efforts to reduce ETO emmissions Flush all endoscope channels with air Can only run full loads (EPA) Can not transfer abator to separate aerating
cabinet
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Cleaning, Disinfection and
Sterilization
Hydrogen Peroxide Gas PlasmaAdvantages
Safe Fast (28-75 minutes cycle time) Good choice for heat sensitive items Simple to install, operate and monitor
Disadvantages Small sterilization chamber Paper linens liquids Restrictions for endoscope lumen size
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Cleaning, Disinfection and
Sterilization
Hydrogen Peroxide Gas PlasmaDisadvantages
Small sterilization chamber Paper, linens, liquids Restrictions for endoscope lumen size Potential toxicity
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Cleaning, Disinfection and
Sterilization
Peracetic Acid Advantages Rapid cycle time Low temperature sterilization Safe (Environment, patients, staff) Sterilant flows through endoscope which
facilitates salt, protein and microbe removal
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Cleaning, Disinfection and
Sterilization
Peracetic Acid Disadvantages Point of use; no sterile storage Material incompatibility Small load capacity Potential hazards Eye and skin damage
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Cleaning, Disinfection and
Sterilization
Steris System 1 Processor Advantages Rapid cycle time Instrument and material compatible Sterilant vs HLD
Steris System 1 Processor Disadvantages Small processing chamber Lack of good biological for routine monitoring Expensive Patented system-must use their sterilants FDA Issues
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Cleaning, Disinfection and
Sterilization
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Cleaning, Disinfection and
Sterilization Steris made changes to their System 1 Processor Did not obtain FDA approval FDA sent warning letter to Steris May 15, 2008
2/19/2009 Steris sent letter to customers to ease fears 12/3/2009 FDA pulled claim for sterilization 12/10/2009 FDA gave 3-6 months to replace 12/17/2009 FDA published alternatives 2/2/2010 FDA extended to 18 months 2/22/2010 FDA Endoscope manufacturers remove system
1 as approved reprocessing method
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm194429.htm
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Cleaning, Disinfection and
SterilizationSEMICRITICAL Items which contact mucous
membranes or nonintact skin must be subjectminimally to high level disinfection (HLD) with achemical disinfectant.
These devices should be free from all microorganismsexcept a small number of bacterial spores
Respiratory therapy and anesthesia equipment Some endoscopes Laryngoscope blades Cystoscopes Esophageal manometry probes Anorectal manometry catheters Diaphragm fitting rings
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Cleaning, Disinfection and
Sterilization
HLD kill all microorganisms except asmall number of spores HLD include: Glutaraldehyde (Cidex, Metricide) H2O2 (Sterrad) Ortho-phthalaldehyde (Cidex OPA,
Opaciden)
Peracetic acid with H2O2 (Peract,Endospore Plus)
Cleared by the Food and Drug Administration (FDA)and are dependable high-level disinfectants providedthe factors influencing germicidal procedures are met .
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Cleaning, Disinfection and
Sterilization
Glutaraldehyde Advantages Inexpensive Excellent materials compatibility Need pH 7.5-8.5
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Cleaning, Disinfection and
Sterilization
Glutaraldehyde Disadvantages Some organisms resistant Efficacy decreases after few days in AERs Respiratory irritation from vapors Residual organic materials fixed to surfaces Test strips expire Exposure can cause colitis Need to monitor exposure
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Cleaning, Disinfection and
Sterilization
H2O2Advantages No activation necessary No odor or irritation Does not fix residual organic materials Inactivates Crytosporidium
H2O2 Disadvantages Material compatibility concerns Serious eye damage with contact
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Cleaning, Disinfection and
Sterilization
Ortho-phthalaldehyde Advantages Fast acting No activation Odor not significant Excellent materials compatibility Does not fix organic materials
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Cleaning, Disinfection and
Sterilization
Ortho-phthalaldehyde Disadvantages Stains skin, mucous membranes, clothing,
surfaces
Hypersensitivity with repeated exposure Eye irritant Slow sporicidal activity
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Cleaning, Disinfection and
Sterilization
Peracetic acid with H2O2 Advantages No activation necessary No odor /irritation
Disadvantages Material compatibility concerns Potential for eye skin damage Limited clinical experience Need longer exposure times for certain
organisms
Poor rinsing is associated with PMC-likeenteritis
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Cleaning, Disinfection and
Sterilization
NONCRITICAL Items which only come
into contact with intact skin. Intact skin
is an effective barrier to mostmicroorganisms, therefore sterility is not
critical.
Two types:
noncritical patient care items noncritical environmental surfaces
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Cleaning, Disinfection and
Sterilization
Noncritical patient care: Bedpans Blood pressure cuffs Crutches Computers
Noncritical environmental surface: Bed rails Some food utensils Bedside tables Patient furniture Floors
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Cleaning, Disinfection and
Sterilization
Noncritical items are subject tointermediate or low level disinfection.
EPA Contact time = 10 minutes Phenolics (Intermediate or low) Quaternary Ammonium Compounds (Quats) -
Low
Ethyl or Isopropyl alcohol (70-90%) (Intermediate)
Household bleach (5.25-6.15%) (Low 1:10dilution, Intermediate 1:100)
Iodophors (low)
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Cleaning, Disinfection and
Sterilization Cleaning must be accomplished thoroughly
prior to disinfection or sterilization
Organic and inorganic materials remainingwill interfere
Decontamination
Cleaning
Decontamination is the process of removingmicroorganisms so objects are safe to handle,use or discard.
Cleaning agents typically are phenolics orquats
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Cleaning, Disinfection and
Sterilization
Endoscope cleaningAll endoscopes must be decontaminated
and cleaned immediately after use and prior
to HLD
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Cleaning, Disinfection and
Sterilization
Mechanically and meticulously cleaninternal and external surfaces, including
brushing internal channels and flushing
each internal channel with water and a
detergent or enzymatic cleaners (leak
testing is recommended for endoscopes
before immersion).
HLD or sterilize
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Cleaning, Disinfection and
Sterilization
Final Drying process A MUST Flush all channels with 70% alcohol Purge with air
SGNA position statement HLD H2O container, cap and tubing daily and
dry completely
Greatly reduces microbialrecontamination from waterbornepathogens
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"Our bravest and best lessons are not
learned through success, but through
misadventure."
-Amos Bronson Alcott
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Thank You!
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